328 FDCs banned in blow to drug firms

The Indian government has banned 328 combination drugs in a blow to domestic and foreign pharmaceutical firms, but the ban has been cheered by health activists worried about growing antibiotic resistance.

The Indian government had in 2016 banned about 350 such drugs, referred to as fixed-dose combinations (FDCs), but the industry mounted legal challenges that prompted the Supreme Court to call for a review by an advisory board.

The Health Ministry on Wednesday said the board had found there was “no therapeutic justification for the ingredients in 328 FDCs and that these FDCs may involve risk to human beings”. It said it was prohibiting the “manufacture for sale, sale or distribution for human use” of the 328 FDCs with immediate effect. It did not name the drugs or give any brands.

The president of the Indian Drug Manufacturers’ Association, Deepnath Roychowdhury, said the order would have an impact on a market worth an estimated Rs16 billion rupees a year for such drugs, which are produced by both small and large pharmaceutical companies. He said the verdict would be respected.